# K082962: Tivamed Cooled RF System, Model 78001

- Pathway: 510(k) (Traditional)
- Applicant: Tivamed, Inc.
- Decided: Dec 4, 2008 after 62 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943450 (1995). 24 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000944: Thermage Thermacool System, Thermage, Inc. (2000) Summary page 1.
- K013639: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.

## Most influential descendants
- K162547: Viveve System (2016), 6 descendants of its own
- K180584: Viveve RF System, Secure (2018), 5 descendants of its own
- K190422: Viveve System 2.0 (2019), 4 descendants of its own
- K200472: Viveve System (2020), 2 descendants of its own
- K193611: Viveve 2.0 System (2020), 2 descendants of its own

## Indications for use
The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K082962
Methodology: https://510kreport.com/methodology